Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
G:DATA
Feasibility Study for the Use of Computer Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
1 other identifier
interventional
30
1 country
1
Brief Summary
This study will test G:DATA, a simple computer game designed to diagnose Alzheimer's Disease, in three different groups of people, some of whom have Alzheimer's Disease. It will look at whether the results of G:DATA match the results of tests that are used to diagnose people with Alzheimer's Disease now. The Investigators will also ask patients and healthcare staff for participant views on the G:DATA game.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 21, 2023
September 1, 2023
3 months
September 2, 2023
September 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
In Game Navigation Test Score
In Game Navigational Test Score of each participant in correlation to clinical assessment score. This doesn't use any form of scale and higher scores refer to worse outcome.
9 months
Study Arms (3)
Early AD
EXPERIMENTAL10 participants with early AD Intervention: Game
MCI
EXPERIMENTAL10 participants with mild cognitive impairment Intervention: Game
Health Control
ACTIVE COMPARATOR10 healthy control participants Intervention: Game
Interventions
Eligibility Criteria
You may qualify if:
- Aged between 55-79 years
- Willing and able to provide informed consen-
You may not qualify if:
- A concurrent diagnosis of epilepsy
- A history of severe visual impairment, e.g. macular degeneration, diabetic reti-nopathy, as determined by the clinical team
- A history of head trauma
- Presence of Sleep Apnoea
- History of alcohol dependence
- History of illicit drug use
- Severe upper limb arthropathy
- The use of cognitive enhancing drugs e.g. cholinesterase inhibitors-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ascentys Ltdlead
Study Sites (1)
Hywel Dda University Health Board
Carmarthen, Wales, SA31 3BB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2023
First Posted
September 21, 2023
Study Start
October 2, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- start date 01/09/23 end date 31/12/23 I couldn't select the no ipd sharing option
- Access Criteria
- no one beyond the study team will be able to access data I couldn't select the no ipd sharing option
Participants will be assigned a unique study ID and data collected will be labelled with the study ID only. An enrolment log will record participant name, date of birth and hospital or NHS number. No personal identifiable information will be included as part of the research dataset leaving the local site for analysis.